Glioblastoma multiforme
Conditions
Interventions
exprimental group:Tumor Treating Fields+PETF + Temozolomide
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with GBM confirmed by pathological examination after brain surgery (patients with total, partial and biopsy are acceptable) and according to the 2016 World Health Organization (WHO) classification criteria; 2. Aged>=18 years; 3. Supra-tentorial tumors; 4. Standard concomitant chemoradiotherapy has been completed: total dose of radiotherapy (RT) is about 60 Gy, and TMZ chemotherapy (75 mg/m^2); 5. TMZ adjuvant chemotherapy of 150-200 mg/(m^2.d) is planned, which is discontinued for 23 days after 5 consecutive days of each 28-day cycle, and 6 cycles are planned to be completed; 6. Karnofsky score>=70; 7. Life expectancy>=3 months; 8. Fertile subjects (defined in addendum I) must agree to use effective contraception during the trial; 9. The subjects agree to participate the trial and sign informed consent form; 10. Start concomitant chemoradiotherapy within 6 weeks (<=6 weeks) after brain surgery; 11. The inital time of TTF treatment is the 29th to the 49th day after the end of RT+TMZ treatment; 12. The dose of corticosteroid within 7 days before randomization is stable or reduced.
Exclusion criteria
Exclusion criteria: 1. Early progression of GBM occurred after the end of TMZ + RT treatment. The suspected pseudoprogression need to be excluded by imaging examination; 2. Subject have received any other cytotoxic or biological antineoplastic treatment before enrollment; 3. Subject is also enrolled in another clinical trial or pregnant or lactating; 4. Before enrollment, the bone marrow and liver and kidney functions of the subjects must meet certain criteria, and they cannot be enrolled in any of the following circumstances: (1) Thrombocytopenia (platelet count 1.7 mg/dL, or>150 micromol/L); (7) Implanted electronic medical device in the brain (e.g., deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, cardiac pacemaker, cardiac defibrillator, etc.); (8) Infra-tentorial tumors; (9) Subjects with multifocal glioblastoma; (10) Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness); (11) History of hypersensitivity reaction to Temozolomide; (12) Skull defects or residual metal fragments within the skull; (13) Allergic to conductive hydrogels; (14) Subject who is judged ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival at 6 months;1-year and 2-year survival rates;The best objective assessment for glioma mitigation;Quality of Life assessment;Karnofsky Performance Status;Self Rating Anxiety Scale;Medical Research Council;Mini Menta l State Examination;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactLiang Chen
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed